The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Aft System Iii.
Device ID | K830214 |
510k Number | K830214 |
Device Name: | AFT SYSTEM III |
Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
Applicant | CALBIOCHEM-BEHRING CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DHN |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-24 |
Decision Date | 1983-03-09 |